Regulatory Material definition

Regulatory Material means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Product.

Regulatory Material means regulatory applications and authorizations or clearances (including INDs), correspondence, records, filings, submissions, registrations or other filings made to, received from or otherwise conducted with the FDA (including minutes of meetings with the FDA) or any other regulatory authority.

Regulatory Material means any documentation drawn up by the Agency pursuant to Article 14(2) of Regulation (EC) No 1592/2002.

Examples of Regulatory Material in a sentence

• Regulatory material relating to North Atlantic aircraft operations is contained in relevant ICAO Annexes, PANS/ATM (Doc.4444), Regional Supplementary Procedures (Doc.7030), State AIPs and current NOTAMs, which should be read in conjunction with the material contained in this Document.

• Regulatory material is found in 23 CFR 650.201.• The Intermodal Surface Transportation Efficiency Act (ISTEA) of 1991 provided authorization for highways, highway safety, and mass transportation for six years.

• In order to achieve harmonization with future proposed changes to the CARs, contemporary CRM training will contain material mirroring the latest ICAO, EASA, and FAA guidance and Regulatory material applicable to the Canadian aviation industry.

• Regulatory material is revised and relocated from appendix A to subpart C.Section 65.51 Certificate RequiredSection 65.51 contains the basic requirements for an aircraft dispatcher certificate and also requires each person who holds an aircraft dispatcher certificate to present it for inspection upon request of the Administrator or other authorized official.

• MISSION AND AUTHORITY‌ The NRC OIG was established on April 15, 1989, pursuant to Inspector General Act Amendments (the Act) contained in Public Law 100-504.

More Definitions of Regulatory Material

Regulatory Material means regulatory submissions and approvals including, without limitation, clinical trial data, Toxicology and Bioavailability Studies, IND, NDA, clinical trial exemption, governmental pricing approvals, and any other foreign equivalents to the extent such material is generated under this Agreement and is solely related to the Field.

Regulatory Material means regulatory applications (including the NDA Amendment), submissions, notifications, communications, correspondence, registrations, NDA Approval or other filings made to, received from or otherwise conducted with the FDA(including minutes of meeting with the FDA) that are necessary or relate to the Development, Manufacture or Commercialization of Product for the Licensed Territory.

Regulatory Material means all of the following, in each case solely to the extent related to the Compounds, and any product containing any Compound, that are owned, in the possession or under the control of Seller or any of its Affiliates (and intellectual property and proprietary rights in or associated therewith): (i) technological, scientific, development, chemical, biological, pharmacological, toxicological, regulatory, R&D notebooks and related materials, (ii) batch records, stability records, methods and other records and information required to support the manufacture, composition, use, distribution, marketing, promotion, sale, administration or formulation of the Compounds, (iii) product safety related information and all other adverse event, complaint files and other reports and information relating to the Compounds or any product containing any Compound(s), (iv) written correspondence with any other Regulatory Authority and all supporting documents with respect thereto and (v) other data, files, records and other information (in any form or medium, wherever located) similar to the foregoing.

Regulatory Material means either of the following: proposals from EASA to the European Commission for amendments to the Basic Regulation and to the delegated and implementing acts to be adopted on the basis thereof, certification specifications or other detailed specifications, acceptable means of compliance, or guidance material;

Regulatory Material means regulatory applications (including the IND and NDA), submissions, notifications, communications, correspondence, registrations (including the NDA Approval) or other filings made to, received from or otherwise conducted with the FDA (including minutes of meetings with the FDA) that are Controlled by DURECT and are necessary or reasonably useful to Exploit Licensed Product in the Licensed Territory.

Regulatory Material means any and all regulatory applications, submissions, notifications, communications, correspondences, registrations, and other filings made to, received from, or otherwise conducted with a Regulatory Authority in order to Develop, manufacture, market, sell, or otherwise Commercialize a pharmaceutical, biologic, or medical device product or any combination thereof in a particular country or jurisdiction, including IDEs, INDs, MAAs, and Regulatory Approvals.

Regulatory Material means regulatory correspondence, submissions, notifications, registrations, approvals and/or other filings, to the extent such material is generated under the terms of this Agreement and is solely related to the Field, made to or with a Regulatory Authority that may be necessary to develop, manufacture, market, sell or otherwise commercialize Product, including, without limitation, clinical trial data, ***-Denotes portions omitted pursuant to a request for confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with the omitted information intact has been filed separately with the Securities and Exchange Commission. toxicology studies, IND, NDA, 510K, clinical trial exemption, Pricing Approvals, and any other foreign equivalents.